• ProAir Digihaler is a breath-activated, dry powder inhaler that contains the bronchodilator medicine called albuterol. “Breath-activated” means the medicine is only released when you inhale. Bronchodilators work by relaxing the muscles in the airways, opening them up and allowing more air to flow into the lungs.
• Albuterol, the active ingredient, works at beta2 receptors in the smooth muscle of the bronchi (the breathing tubes of the lungs). Activation of these receptors leads to smooth muscle relaxation in the lungs and easier breathing. Albuterol is classified as a short-acting beta-agonist (SABA).
• ProAir Digihaler has been developed with special technology. It has a built-in sensor to help capture your inhaler usage data on a mobile application (app) on an electronic device, such as your phone. If you choose, you can share this data with your healthcare provider or others.
• This can help your and your doctor follow your progress when treating your asthma or chronic obstructive pulmonary disease (COPD). Using your fast-acting inhaler too often may mean that your condition is not well-controlled.

• ProAir Digihaler is a prescription medicine used for sudden breathing problems in patients living with lung conditions like asthma and chronic obstructive pulmonary disease (COPD). It contains the medicine albuterol and is often referred to as a “fast-acting inhaler”
• It is approved for two uses in people 4 years of age and older: to help treat or prevent sudden breathing problems (bronchospasm) in people who have reversible obstructive airway disease, and to help prevent exercise-induced bronchospasm.
• ProAir Digihaler contains built-in smart sensors that allow you to capture, store and send your inhaler use data to a companion mobile app using Bluetooth wireless technology. You do not have to activate the app or capture data for ProAir Digihaler to provide the medicine.
• ProAir Digihaler provides information about how often you use the inhaler and how well you inhale by measuring the strength of your inhalations. By reviewing this data, you and your doctor can better manage your asthma or COPD treatment plan.
• Dry powder in an inhaler has advantages over aerosols: it eliminates the need for hand-breath coordination during inhalation and you don’t have to coordinate pressing and inhaling your dose at the same time. Also, you do not need to prime the inhaler, wash it, shake it before use, or use a spacer.
• Can be stored at room temperature between 59ºF and 77ºF (15ºC and 25ºC). Keep the inhaler clean and dry at all times; however, routine maintenance is not required. Wipe with a dry cloth if needed.
• If you have commercial insurance and prefer the ProAir Digihaler, Teva Pharmaceuticals, the manufacturer, may offer a copay card to help lower your cost.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Back pain, body aches and pain, upset stomach, sinus headache, urinary tract infection, pounding or fast heart rate, chest pain, common cold symptoms (stuffy or runny nose, sore throat), throat or mouth pain, nervousness, dizziness, or vomiting.
• Use may increase your blood sugar or lower your potassium blood levels. Your doctor may monitor your levels with blood tests.
• Rarely may lead to worsening trouble breathing, coughing and wheezing (called paradoxical bronchospasm), when your airways close up instead of open. If this happens, stop using ProAir Digihaler and call your doctor or emergency medical services (911) right away.
• May cause heart problems, like a faster heart rate and higher blood pressure.
• Excessive use may cause death in people with asthma.
• ProAir Digihaler may be more expensive than other albuterol inhalers if you are paying cash. ProAir Digihaler is about twice the cost of ProAir Respiclick. Check with your insurance for coverage.
• Prices are variable, but in general the price for the ProAir Digihaler dry powder inhaler (90 mcg/inh) is about $170 for one inhaler (200 doses). No generic alternative to the ProAir Digihaler is available at this time.
• Do not use this product if you have a severe allergy to albuterol or to milk proteins like lactose. Lactose is an inactive ingredient in ProAir Digihaler.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Registration is required to be able to share data from your ProAir Digihaler. Download the app and register your account from your mobile phone. For assistance, call the activation registration hotline at 1-800-603-0788. ProAir Digihaler is manufactured by Teva Pharmaceuticals.
• Always follow your doctor’s specific directions. Do not increase your inhaler dose or take extra doses without first contacting your healthcare provider. Excessive use may be fatal.
• ProAir Digihaler is not a substitute for corticosteroids used for long-acting control of breathing problems like asthma.
• If you have heart problems or a seizure condition, tell your doctor before treatment.
• Call your doctor right away if you have symptoms of an allergic reaction, such as itchy skin, swelling beneath your skin or in your throat, a rash, or worsening trouble breathing.
• ProAir Digihaler does not need priming like aerosol inhalers.
• The inhaler has a dose counter to let you know when it’s time to refill your prescription and holds 200 inhalation doses. When there are 20 doses left, the dose counter will change to red. When you see the red, you should refill your prescription or request another prescription from your healthcare provider.
• In general, the technique for administering ProAir Digihaler to children is similar to that for adults. Children should use ProAir Digihaler under adult supervision, as instructed by the patient’s physician.
• You should not use a spacer or volume holding chamber with ProAir Digihaler, as the medicine is not an aerosol but a dry-powder that you inhale directly into your lungs.
• If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water.
• Throw away the inhaler 13 months after opening the foil pouch, when the dose counter displays 0, or when the product expires, whichever comes first. Keep away from children and pets at all times.
• Albuterol is also available as an aerosol metered-dose inhaler (ProAir HFA), a dry powder inhaler without the electronic sensor (ProAir Respiclick), a nebulizing solution, an oral syrup, and as tablets and extended-release tablets.

• Effects of albuterol usually last 4 to 6 hours, but possibly longer in some patients. Do increase the dose of albuterol or to take it more frequently unless directed by your doctor.
• Contatc your doctor right away if the effects of your medicine seem to wear off more quickly. This may mean your breathing condition is getting worse and you may need additional or alternative treatments.
• Albuterol can also be fatal if you take too much or experience an overdose. If you or someone you know have taken too much albuterol, seek emergency medical help (by calling 911) or call the Poison Control Center Helpline at 1-800-222-1222.

• antibiotics, such as azithromycin
• astemizole
• atomoxetine
• digoxin, may decrease blood levels
• diuretics, such as furosemide or HCTZ which may affect potassium levels
• epinephrine
• heart medicines called beta-blockers, such as atenolol or carvedilol
• linezolid
• medicines that increase the QT-interval, such as haloperidol
• monoamine oxidase inhibitors, such as selegiline, isocarboxazid, or phenelzine
• ondansetron
• other short-acting inhaled bronchodilators, like levalbuterol
• tricyclic antidepressants, such as amitriptyline, imipramine, or nortriptyline

Note that this list is not all-inclusive and includes only common medications that may interact with albuterol. You should refer to the prescribing information for albuterol for a complete list of interactions.